AVANT Immunotherapeutics has received a $2-million milestone payment from GlaxoSmithKline (GSK). This payment marks the acceptance for review by the European regulatory authorities (EMEA) of a marketing application for the Rotarix rotavirus vaccine, the first regulatory submission by GSK for approval of Rotarix in a major commercial market.
"We are very gratified to receive this milestone payment, which marks a key event in the worldwide commercialization of Rotarix," Una S. Ryan, AVANT president and CEO said adding, "Last year, we saw the first commercial approval for Rotarix in Mexico, and over the course of the next several years, we expect GSK to extend the marketing approvals for this product on a global basis."
Rotarix is an oral, two-dose, live attenuated vaccine against rotavirus disease in infants that was licensed in 1997 by AVANT Immunotherapeutics to GSK for worldwide commercialization. Dr. Richard Ward originally developed the vaccine at Cincinnati Children's Hospital Medical Centre.
Rotavirus infection is the leading cause of severe diarrhoea and vomiting in infants and young children between 3-24 months worldwide.
More than 70,000 infants have been enrolled in the global clinical development programme, with studies conducted in Europe, the US, Latin America and Asia to evaluate the safety and efficacy of Rotarix, the company says.